Proceedings of the November 2011 Traceability Research Summit
This report is the third in a series on Traceability Summits sponsored by IFT beginning in July 2011
Fifty thought leaders in the area of food traceability met for a 3rd time to discuss methodologies and finalize the principles that define their vision for traceability. Participants in the summit included representatives from industry, trade associations, government, academia, consumer groups, and more.
One main focus of this summit included a discussion on the current regulations and voluntary initiatives in place regarding traceability. Overall, it was recognized that the recommendations from this summit group would be more specific and stringent in comparison to these current regulations and initiatives. The participants sought to be leaders in the traceability arena, with their recommendations leading the industry to optimal traceability systems and methods.
Participants agreed on many principles for their vision of traceability, emphasizing the importance of access to traceability data. They discussed having industry be asked for “basic” tracing data prior to the need for a large-scale investigation, having standards for sharing data, and having the data in electronic form. Participants foresaw the importance of capturing data electronically in the future, although they recognized that many firms do not currently do this. The group also saw a need for a transition period to implement changes, and to provide implementation training and resource aid to small businesses.
Summit participants discussed specific definitions and examples for key data elements and critical tracking events that could be used by industry to capture tracing data at specific points within the supply chain. Overall, participants refined the goals of the summit group and started to identify specific ways to achieve those goals.
The Institute of Food Technologists (IFT) previously organized and held 2 traceability summits in July and August of 2011 to bring industry leaders and stakeholders together to define a vision for food traceability. After the first 2 summits, it was deemed necessary to host a 3rd summit to continue the conversations of this diverse group of traceability experts. IFT's Traceability Improvement Initiative (with support from BASF, Underwriters Laboratories, and the Seafood Industry Research Fund) held the 3rd summit on November 1, 2011. The summit was hosted by PepsiCo, at the PepsiCo Sustainability Center in Chicago, Ill., U.S.A. At the prior July 2011 Traceability Research Summit, the group determined that “the development of a common vision for a simple, low cost, acceptable and implementable traceability system model” was necessary. At the August 2011 Traceability Summit, the group learned from one another about the past and current industry and association-led traceability pilots and projects. The goals and frameworks surrounding traceability were also clarified. After this summit, a volunteer workgroup formed (a subset of the summit participants) to prepare materials based on the content of the previous 2 summits and to help facilitate discussions at the November summit. The traceability guidance table (Table 1) was a large part of the discussion at this third summit (further described below). In addition, multiple presentations were made, showcasing the current principles and ideas from the workgroup and other involved subject matter experts. Participants were then separated into 4 subgroups to efficiently analyze the traceability guidance table and provide feedback. The 4 groups later came back together in order to provide consensus on the changes to be made to the traceability guidance table and to discuss the possible benefits and return on investment (ROI) that could be associated with food traceability. The overarching goal of this summit was to have the group refine the concepts presented by the workgroup and experts, and have general agreement with the principles within these presentations.
Table 1. –Traceability guidance table
Suggested Principles and Approaches
Taking into consideration the content at the first 2 summits, the working group produced 10 principles to share with the participants at the November summit. These principles were presented, discussed, modified, and agreed upon by the group at the 3rd summit:
- 1.The goal of traceability is to enable access to relevant, reliable, and standardized information as rapidly as possible, so that it can be assimilated and analyzed to enable decision making.
As important as data capture within a firm can be, the group put emphasis on the ability for traceability information to be shared and understood by those who are managing the traceback or traceforward investigations. Many participants thought that industry was already capturing the majority of traceability information that is needed.
- 2.Information accessibility is a key characteristic for traceability—this will drive speed of response and precision of analysis. More detailed data may be required in certain scenarios, but the focus should be on first response before tackling possible further inquiries that will “drill into” specific data systems.
The participants thoroughly discussed Principle 2. It was suggested that a set of basic prescribed data should be requested within a short time. After the analysis of the basic data, additional information could then be requested if needed. Requesting a smaller initial set of prescribed data will shorten the time that industry needs to produce data, and will allow for quicker large-scale view of the supply chain. This short turnaround could lead to suspected product convergence more quickly.
- 3.The basic data required for initial traceability requirements is relatively small. The data (attributes designated as necessary) must be accessible electronically in a standardized format.
“Basic data” refer to the general data about the products in question that could be used to look at the flow of the product. Having a “standardized format” required of industry would not require companies to prescribe to a specific technology or system, but could require that all firms submit the requested information in a specified format to regulatory agencies. Participants also discussed the possibility of having formats differ by firm or product type. Currently, there are no specific standards related to data sharing in a traceback event, causing firms to submit data that can look vastly different from others, and could come in many forms. This causes much confusion and can slow down the process of analyzing the tracing data. The group suggests that basic data requested be in an electronic format, regardless of the type of format that industry uses to collect data internally, so that they can be analyzed more easily.
- 4.Electronic data gathering and capture are considered preferable to manual (human data entry) practices.
It was acknowledged that some firms do not capture data electronically, but that it should be a goal of the industry in the future to have data captured in electronic format.
- 5.There should be flexibility in the implementation of traceability solutions and systems so that firms may meet traceability requirements in a manner that makes business sense.
With a diverse group of summit participants, it was clear that many different types of traceability practices exist within the industry. Although the group members did recommend using a standard format for reporting, they also agreed that firms must be able to choose their own traceability solutions and systems to meet the traceability data sharing requirements. Individual firms should all have their own say in how to implement new traceability practices.
- 6.Smaller businesses may need help with regards to the technical systems for traceability (for example, use of a web portal for reporting of trace information).
It was acknowledged that smaller businesses may need outside help if implementation of new technologies would be required for improved traceability. The participants believed that small businesses must abide by the same requirements for recordkeeping and sharing traceability data as larger firms, which would ideally be in electronic form. Regulatory agencies and trade associations could help provide aid to these smaller businesses in education and implementation.
- 7.A transition period will need to be considered in order to allow industry participants time to invest in changes to operational processes, IT, and manufacturing technology.
A transition period for the implementation of new traceability practices was seen as necessary. There was some discussion about having different lengths of transition periods for different types of firms, but specific lengths were not fully explored or agreed upon. The length of these transition periods could be variable based on the severity of changes that need to be made, firm type, firm size, and so on.
- 8.The group was not endorsing any specific standard related to data definitions or messaging; however, it is recognized that data must be readily accessible in common formats and that any standards used should be globally recognized.
Common formats were seen as important for future traceability, especially having those standards recognized globally. It was understood that the food supply chain is becoming increasingly global, and to have internal or proprietary standards would not be the best approach across the entire supply chain.
- 9.Reporting or sharing of product trace data should be based on specific requests from regulators or a valid request from a trading partner.
Confidentiality was a large concern for the industry, and participants agreed that product trace data should only be shared in specific scenarios. They also believed that the data should only be shared with regulators or those that the firm agrees to share data with. Other firms will not have access to any other firms’ records without approval.
- 10.A singular database is not considered a feasible solution. There may be a national “data mining tool” that requests data; however, a single system that contains all data is not a practical solution.
A singular database for housing all product traceability data was widely seen by participants as unrealistic and undesirable. Industry participants also indicated that they would have confidentiality issues if such a database were to come into existence.
Although some participants may not have agreed on every aspect of each of these suggested principles, overall there was consensus that they portrayed the overarching goals of the group.
Current standards and regulations relating to traceability were identified at the November summit so that all participants could understand how current and future traceability practices fall within these standards. The U.S. Federal Food, Drug and Cosmetic Act, amended by the Bioterrorism Act of 2002, established requirements for those who manufacture, process, pack, transport, distribute, receive, hold, or import food. These groups are required to keep records that will allow the FDA to identify the immediate previous sources and immediate subsequent recipients of food, known as the “one-up, one-down” approach. Farms, restaurants, and some other firms are excluded from this requirement. Under this rule, FDA can request access to records upon a reasonable belief that a food is adulterated and presents a threat of serious adverse human health consequences or death.
The Reportable Food Registry (RFR) has many parallels with traceability efforts. This electronic portal is available for industry to report articles of food that are out of their possession and may cause serious adverse health consequences, which could help the FDA follow the path of a suspected food more easily. The RFR requires disclosure of each “responsible party's” FDA Facility Registration Number for every reportable event. Due to the confidential nature of Facility Registration Numbers, each party in the supply chain is only knowledgeable of their own Registration Number and thus unable to report Registration Numbers from trade partners. These numbers are all known within the FDA, however. Products regulated solely by the USDA are not part of the RFR. USDA's reportable food system is less extensive than that in the FDA, but it also requires similar data to be shared.
There are other instances where information captured by a traceability system can be useful, such as during the investigation of quality or other nonfood safety concerns, or due to contractual obligations/agreements between trading partners.
The Food Marketing Inst. (FMI), Grocery Manufacturers Assn. (GMA), Natl Grocers Assn. (NGA), and GS1 US come together to produce the Rapid Recall Exchange. This online service enables suppliers to communicate to retailers in the event of a withdrawal or recall event. The data requirements within the Rapid Recall Exchange include some of the same attributes identified earlier and are used by many companies to support both voluntary and mandatory reporting requirements.
All of the above regulations and voluntary efforts have overlapping language and data requirements, and they could all be beneficial if used in conjunction with one another during an outbreak investigation.
Traceability in the Eyes of Consumer Rights Advocates
Caroline Smith DeWaal, from the Center for Science in the Public Interest, led a discussion on how some consumer rights advocates view past legislation and current initiatives in regards to the future of traceability efforts. DeWaal believes that the “one-up, one-down” recordkeeping approach can be improved upon. She explained that the RFR currently houses information from the industry about the foods that may cause serious adverse health consequences, which could help the FDA better protect public health by tracking food distribution patterns and targeting inspections. Other voluntary initiatives could also be useful in traceability investigations, especially the Rapid Recall Exchange. DeWaal believes it would be beneficial for regulatory agencies to align useful information from many different existing sources during a traceback investigation. The data from voluntary initiatives and regulatory requirements could be aggregated to have the most comprehensive information possible. DeWaal also highlighted the importance of including consumers into the traceability supply chain and giving them tools to identify contaminated products that they may have purchased and/or consumed. Consumers also need information on what steps to take if they have contaminated products in their possession. Both consumer education and access to information (labeling, information on firms’ webpages, and so on) are needed to make sure that consumers are informed as best they can be.
Traceability Guidance Table
The traceability guidance table was prepared by a small working group, which worked through e-mails and conference calls after the August summit to review the proceedings from the first 2 summits and develop draft concepts to present to the larger group at the 3rd summit. The traceability guidance table primarily house a table which indicates which key data elements (KDEs) should be mandatory, recommended, or optional for specific critical tracking events (CTEs). Some conversation also surrounded who should be responsible for capturing the KDEs at specific CTEs.
The concepts of KDEs and CTEs were expanded upon and clarified at this summit. Some CTEs had evolved from their original conception and definition. Distinctions were made in the KDE and CTE chart between which data were mandatory, recommended, or optional. In addition, participants discussed what data could be used as “linking information,” or information used to connect one supply chain partner data with another. Commonly, a single firm will boast that it has great traceability, but that traceability is based on having specific product data that may not be available in a traceback investigation. Linking information includes data that links what information a firm has associated with a product internally, with the data surrounding the product coming in, and coming out of that firm's possession.
Specific CTEs were presented to the group to be analyzed and ultimately agreed upon. The 1st CTE discussed was “receiving,” which was defined as “accepting a shipment from another facility.” It was decided that for this CTE, KDEs must be captured for all items received from suppliers, both internal and external. Participants noted that it was important to specifically recommend capturing KDEs on products that travel internally, or within a single company, but may move between 2 separate facilities or locations.
Another CTE presented was “transformation.” It was explained that “anytime a product is modified either in packaging or composition, KDEs must be captured for all items used or created by the process.” There was much discussion surrounding the relabeling of products, as it is considered a “transformation.” Many distributors relabel products, and do not necessarily correlate the specific information they have about the product before it was relabeled with the label that they put on it. In addition to relabeling, it was noted that repackaging a product into smaller, or different, packages would also be a “transformation” of the product.
The next CTE discussed was “shipping,” which stated that “KDEs must be captured for all items shipped—either internally within the enterprise, or externally to a customer.” Similar to the “receiving” CTE, summit participants found it important to note that the shipping CTE should include shipments of product within a company or between different firms.
The next CTE discussed was “depletion.” This CTE description included the following: “KDEs must be captured for all items sold or consumed to produce an item to be sold to a final customer in either a retail or foodservice establishment.” Within this CTE, there were 3 specific types of depletion noted: D1, D2, and D3. D1 was described as “product sold directly to the customer.” D1 depletion CTEs could also include samples or donations, which are not “sold,” but still go directly to a customer. D2 and D3 had clarifications that specific KDEs be included. The D2 description said: “Date/Time product initially used to create a finished product for a customer” and the D3 description said: “Date/Time product used to create a finished product for a customer.” There was much discussion about these specific CTEs, as summit participants thought it would be too difficult for firms to capture information so detailed. Other participants thought it was very important to have firms capture the date and time that a unit of ingredients started to be used and was finished, primarily for bulk ingredients. It is important to capture hard starts and stops in the use of bulk ingredients. It is much easier to trace products with finite data which could lead to a more narrow recall or scope in doing a traceback investigation.
The final CTE discussed was “disposal.” Disposal includes the “date/time product was scrapped or destroyed in a manner to make it unfit for consumption.” The group felt that a distinction needed to be made between product that was out of a firm's hands and would be consumed, compared to product that would be disposed of and not consumed.
The KDEs included in the traceability guidance table were as follows: Date, Time, Source Party, Target Party, Item, Lot/Batch/Serial Number, Quantity, Unit of Measure, Order Number, Order Type, Transfer Number, Transfer Type, Lot/Batch Relevant Date, Carrier ID, Trailer Number, and Pallet ID. Some of the latter KDEs, especially, were more commonly designated as “optional” KDEs to capture during CTEs. Descriptions and examples of the KDEs were discussed but not finalized in writing.
Summit participants suggested that the industry individually determine how to implement traceability efforts, but see the KDEs and CTEs as standards that can and should be used by all systems. The participants agreed that the food industry should always be able to individually choose how to implement changes for improved traceability, and the intent of this group is only to create a framework to which information can be captured. The group recognized that using all KDEs and CTEs defined by this group would be voluntary, and may go beyond what will be mandated by law. Tracing to the case level was recommended by many participants in the summit, but they understand that recommendation will likely not be mirrored in the future FSMA legislation. It was also noted that the group is aware that the food industry is becoming an increasingly global market, and that all future standards need to be flexible in order to incorporate global firms.
Cost versus ROI
At the November summit, participants discussed and updated the ROI information that was previously prepared. Greg Buckley from PepsiCo presented information on the benefits of improved product traceability in regards to public health, the food industry as a whole, and the individual businesses within the supply chain. Relative costs to supply chain partners required to obtain these benefits were not quantified during this summit.
Overall, participants agreed that the primary motivation to improve product tracing is the protection of public health. However, there was recognition that for practical purposes, there must be benefits to those who will incur the cost of implementation, primarily the companies within the food supply chain.
Potential benefits from traceability were segmented into direct and indirect benefits. Direct benefits refer to those which can lead to faster, more efficient, and more targeted recalls, whereas indirect benefits include other supply chain benefits that are potentially enabled by the new capabilities required to support traceability.
It is noted that not all traceability benefits can be directly managed, as some of the impacts are controlled by outside forces, like the media. Suggestions were made to segment the benefits by commodity, size of the company, or maturity of information systems. In addition, the group thought that both short-term and long-term costs need to be considered.
Summit participants believed that traceability benefits may have a “trickle-down” effect, with FDA and the consumer receiving the most benefits from traceability, whereas the retail/foodservice, manufacturer/processor, and farmer stakeholders gaining the least benefits. There are, however, “trickle-up” costs, with most of the cost of enacting improved traceability efforts lying heavily on the farmers, manufacturers, and processors. Many of the incentives to improve traceability within a firm favor less technologically advanced operators because the more advanced operators already have enhanced inventory or tracking systems. Many participants at the summit believed that consumers should share in the cost of traceability, though consumers already assume that all foods are safe and, to an extent, traceable, and they may not be willing to pay more for these improvements.
It should be noted that the costs incurred by the federal government during recalls or tracing activities was not focused upon at this summit.
Assumptions and Limitations
Some assumptions and omissions were made in the production of the principles and the traceability guidance table. In conversations about implementing traceability efforts, emphasis was placed on supply chain benefits. The costs that may be associated with improved traceability implementation will vary dramatically between different firms within the supply chain. It is also difficult to accurately determine the costs of implementing traceability, as new practices/technologies that are put into effect may have benefits outside of traceability itself. Due to these difficulties, traceability summit participants did not aim to specifically determine any costs for improved traceability for the industry as a whole. They instead decided to highlight the positive benefits that can be incurred by adopting better traceability standards, which include improved inventory management and production management efficiency. In addition, some consumers may be willing to pay more for “easily traceable” products for marketing reasons, such as highlighting that the product is organic, natural, sustainable, local, allergen-free, and so on. It was noted that consumer education and understanding of the importance of product tracing is imperative as changes to better traceability systems are made. Benefits of improved product tracing were highlighted in the document, as the negative consequences such as cost and time are more commonly associated with change in this area.
There was consensus that firms’ traceability data must be continually captured, but not necessarily continually shared. The 3rd summit attendees continued to emphasize that sharing information should be up to industry participants, and each facility should have the power to accept or deny queries for specific traceability information.
Summit attendees believed that brokers should be considered responsible parties and should, therefore, keep their own records or be aware of the records that their suppliers are keeping, as well as the records for those that they supply products to.
Consumers could benefit greatly from traceability practices, as some illnesses and deaths could be prevented by being able to quickly determine exactly which foods are implicated and need to be recalled or disposed of. Summit participants believed that consumers currently have an expectation that all foods are safe and traceable. Many, including consumer rights advocates, believed that consumers need an efficient way to identify recalled foods that they might have in their possession and also need increased education on food safety and product tracing.
The workgroup will edit the documents which describe the KDEs, CTEs and ROI information. This document will be available in a draft form with the intent to receive feedback and be built upon in the future. The group felt strongly about having good and consistent definitions, ideally put into a white paper. The group suggested that scenarios for the CTEs and KDEs be formed in addition to a glossary, to help illustrate the use of the CTEs and KDEs in data capturing.
Recommendations from this summit will be documented and available for use in the IFT/FDA food traceability pilot projects. Recommendations will also be available for trade associations, hopefully with further dissemination to the industry and public. Trade associations are seen as some of the main drivers in disseminating the work and ideas shared at the summits. It was noted that many of the recommendations will be used in a voluntary capacity by the industry, and could be considered “best practices,” in addition to regulatory guidance. This group hopes that the recommendations will be widely accepted within the industry, and will primarily be an industry- and association-driven change that is necessary for better product tracing. Continued work will also be necessary to finalize a cost/benefit analysis and return of investment analysis in implementing better traceability methods.
IFT greatly appreciates the financial support provided to the Traceability Improvement Initiative by silver level partners BASF Nutrition & Health and Underwriters Laboratories, and by bronze level partner the Seafood Industry Research Fund. IFT also expresses gratitude to PepsiCo for sponsoring the availability of conference facilities for the November Summit.
IFT appreciates the efforts of Brian Sterling (OnTrace), Jennifer McEntire (Leavitt Partners LLC), and Tejas Bhatt (IFT) for capturing the essence of the conversations.
In addition, the active participation of all attendees was critical to the success of this event, and IFT thanks everyone who took the time to attend:
David Acheson, Leavitt Partners LLC; Chris Balestrini, GMA; Tejas Bhatt, IFT; Barbara Blakistone, Natl. Fisheries Inst.; Jonathan Brania, Underwriters Laboratories; Greg Buckley, PepsiCo Inc.; Bob Bunsey, Standard Platform for Electronic Data Entry Technologies; Jeffrey Chester, Food Service of America; Karla Clendenin, Florida Dept. of Agriculture; Clay Detlefsen, Intl. Dairy Foods Assn.; Sue Fangmann, McDonald's Corp.; Faye Feldstein, Deloitte Consulting; Mark Galletta, Nestle-USA; Patty Harvey, ConAgra Foods; Caitlin Hickey, IFT (current affiliation Deloitte and Touché LLC); Ana Hooper, Darden; Catherine Adams Hutt, Natl. Restaurant Assn.; Amanda Josey, BASF Corp.; Andrew Kennedy, FoodLogiQ LLC; Helge Kittleson, Tracetracker Canada; Qingyue Ling, Oregon State Univ.; Paul Lothian, Tyson Foods, Inc.; Steve Mavity, Bumble Bee Foods; Jennifer McEntire, Leavitt Partners LLC; Sherri McGarry, Food and Drug Administration, Coordinated Outbreak Response and Evaluation, Office of Foods; Joan McGlockton, Natl. Restaurant Assn.; Benjamin Miller, Minnesota Dept. of Agriculture; Melanie Neumann, PricewaterhouseCoopers; Vikki Nicholson, U.S. Dairy Export Council; Jan Morritz Olsson, TraceTracker AS; Gale Prince, Your Food Safety Coach; Kevin Richardson, Heartland Solutions Group Inc.; Michael Roberson, Publix Super Markets Inc.; Michele Samarya-Timm, Health Educator, Somerset County, N.J.; Caroline Smith DeWaal, Center for Science in the Public Interest; Hilary Thesmar, FMI; Ed Treacy, Produce Marketing Assn.